Trial of Rehabilitation in Phase 1 After Coronary Artery Bypass Grafting

NCT ID: NCT01941355

Last Updated: 2015-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-04-30

Brief Summary

Patients undergoing coronary artery bypass graft surgery often experience a range of problems and symptoms related to the procedure and the underlying heart disease. These problems include anxiety and depressive symptoms, immobility issues, complications such as wound seeping, neck and shoulder pains, interrupted and insufficient sleep. Over the last 2 decades, cardiac rehabilitation has become recognized as a significant component in the continuum of care for persons with cardiovascular disease. Furthermore, cardiac rehabilitation has undergone a significant evolution moving from a focused exercise intervention to a comprehensive disease management program. In Guidelines for Coronary Artery Bypass Graft Surgery cardiac rehabilitation is described to include early ambulation during hospitalisation, and outpatient prescriptive exercise training beginning 6-8 weeks following surgery. Our hypothesis is that physical exercise with moderate intensity and a psycho-educative component as a part of cardiac rehabilitation can begin in early postoperatively during hospitalising. Results from studies on phase 1 rehabilitation in coronary artery bypass graft surgery patients are promising. However, no randomised trials have been conducted, and evidence is therefore lacking.

The objective of this pilot trial is to investigate the effect of a phase 1 comprehensive cardiac rehabilitation programme consisting of a psycho-educative component, an exercise-training component including pulmonary training, cycling, neck and shoulder exercises, these in combination plus treatment as usual and treatment as usual in patients who undergo coronary artery bypass grafting.

SheppHeartCABG is an investigator-initiated 2 x 2 factorial randomised clinical pilot trial with blinded outcome assessment. Recruitment from one site with 1:1:1:1 central randomisation to phase 1 rehabilitation; 1) exercise-training plus usual care, 2) psycho-educative plus usual care 3) exercise-training and psycho-educative plus usual, 4) usual care alone.

Detailed Description

The explorative outcome measures consist of two parts: physical capacity and mental and physical health. Physical capacity is measured by peak VO2 max and 6 minutes' walk test at discharge and 4 weeks following surgery. Perceived mental and physical health is measured by the Medical Outcome Study Short Form 36 (SF-36) at admission, discharge and 4 weeks following surgery. Furthermore questionnaires measuring anxiety and depression (Hospital Anxiety and Depression Scale), health-related quality of life (HeartQoL), fatigue (MFI-20) cognitive and emotional representation of illness (B-IPQ), physical activity (IPAQ), self-rated health (EQ-5D), sleep (PSQI) and pain (ÖMPSQ)

Conditions

Ischaemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise training, psycho-educative

Group Type: EXPERIMENTAL

Exercise training component

Intervention Type: BEHAVIORAL

The physical exercises consist of; deep breathing exercises and breathing exercises using incentive spirometry with expiratory positive pressure airway, cycling exercises during hospitalisation and an individualised exercise programme running from discharge to 4 weeks following surgery.

Psycho-educative component

Intervention Type: BEHAVIORAL

The psycho-educative rehabilitation programme consists of four psycho-educative consultations with a specially trained nurse. The last consultation will take place 4 weeks following surgery.

Psycho-educative component

Group Type: EXPERIMENTAL

Psycho-educative component

Intervention Type: BEHAVIORAL

The psycho-educative rehabilitation programme consists of four psycho-educative consultations with a specially trained nurse. The last consultation will take place 4 weeks following surgery.

Exercise training component

Group Type: EXPERIMENTAL

Exercise training component

Intervention Type: BEHAVIORAL

The physical exercises consist of; deep breathing exercises and breathing exercises using incentive spirometry with expiratory positive pressure airway, cycling exercises during hospitalisation and an individualised exercise programme running from discharge to 4 weeks following surgery.

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise training component

The physical exercises consist of; deep breathing exercises and breathing exercises using incentive spirometry with expiratory positive pressure airway, cycling exercises during hospitalisation and an individualised exercise programme running from discharge to 4 weeks following surgery.

Intervention Type: BEHAVIORAL

Psycho-educative component

The psycho-educative rehabilitation programme consists of four psycho-educative consultations with a specially trained nurse. The last consultation will take place 4 weeks following surgery.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 years or older.
• Persons with ischaemic heart disease referred to elective coronary artery bypass graft surgery.
• Speaks and understands Danish.
• Provide written informed consent.

Exclusion Criteria

• Patients at intermediate or high risk according to their cardiovascular status
• Patients with illness limiting the ability to exercise.
• Patients without permanent residence.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Selina Kikkenborg Berg

RN, PhD, Post doc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selina K Berg, PhD, Post doc

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

SheppHeartCABG

Identifier Type: -

Identifier Source: org_study_id